Hormonally-timed dermatological preparations

ABSTRACT

This invention provides a dermatological preparation to improve skin cosmesis or conditioning by using different formulations in a sequence that suits the needs of the skin at different points of the hormonal cycle. In its simplest implementation, this would be a two-phase skin treatment, such as a cosmetic, lotion or soap whose formulation changes to balance the differing states of hydration and reactivity of the skin during the early and late phases of the cycle. The formulations would be made in a way to be easily identified and delivered conveniently for use at different times of a hormonal cycle. The preparation would be packaged to permit the convenient purchase and dispensing of the different formulations in a manner that could be easily sequenced with the hormonal cycle.

1. RELATED APPLICATIONS

This application claims priority of U.S. Provisional Application Ser.No. 60/704,296 filed Aug. 1, 2005, which is incorporated herein byreference in its entirety.

2. BACKGROUND

2.1 Field of the Invention

The present invention relates to dermatological preparations, and moreparticularly, to hormonally-timed dermatological preparations.

2.2 Description of the Related Art

Hormones are well-known to affect the condition of the skin. When thesehormonal balances shift, dermatological properties shift as well. Inwomen, menstrual cycling is associated with changes in skin thickness,water retention, blood flow and immune reactivity (Agner, Damm, andSkouby, J. Am. Acad. Dermatol. 24(4):566-70 (1991); Harvell,Hussna-Saeed, and Maibach, Contact Dermatitis 27(5):294-301(1992);Eisenbeiss, Welzel, and Schmeller, Br. J Dermatol 139(3):462-7 (1998);Kirmaz, Yuksel, Mete, Bayrak and Baytur, Asian Pac. J Allergy Immunol.22(4):197-203 2004), as the result of increasing levels first ofestrogen and then of progesterone secretion. Skin reactions to theseshifts are most apparent in a small proportion of women who have frankhypersensitivities to progesterone. These women have obviousdermatological and immunogenic problems during the immediatepremenstrual period, that include skin rashing, acne andhyperpigmentation (Iteskson, Lazarov, Cordoba, Zeitune, Abraham, andSeidman, J. Reprod. Med. 49(3): 195-9 (2004)). As might be anticipated,special cosmetic or therapeutic interventions are often recommended forsuch serious skin reactions, typically during the period whenprogesterone is secreted in high concentrations. Evidence of theimportant role played by cycling hormones is also apparent from theeffects of contraceptive hormones on the skin of premenopausal women.The use of contraceptive hormones is often recommended to young women tostabilize hormone levels because this is associated with a reduction inacne (Cibula, Paseka, Unzeitig, Horejsi, Rotta, and Chroust, CeskaGynekol. 65(2):79-82 (2000)). Loss of cyclical hormone production atmenopause is associated with thinning of the skin, decreased collagenand sebum production and reduced healing capacity (Shah and Maibach, Am.J. Clin. Dermatol. 2(3):143-50 (2001)). These conditions can bemitigated by hormone replacement therapies. Some women, in fact, chooseto continue with hormonal therapy to control the symptoms of menopauseand enhance the appearance of their skin despite concerns about cardiacor other complications. Commonly, replacement therapies attempt to mimicthe normal cycling of the hormones by first supplementing estrogen, andthen later adding progesterone to replicate the patterns of hormonalcycling typical of the menstrual pattern. However, the less pathologicskin conditions that do not require drug therapy but are present widelyin the general population have not received much attention whendeveloping skin treatments, lotions, cosmetics and soaps.

A knowledge of the physiological effects that normal or imposed hormonalcycling has on the skin may be used to improve the formulation andtiming of dermatological products most suitable for the skin atdifferent points in the cycle. Many products have been developed toenhance skin properties or appearance, but these are marketed for use atall time points throughout a monthly cycle. Typically a woman will buy asingle facial moisturizer or soap that is used continuously, even whenthe woman is dissatisfied with the product for some of the time. Thereis a failure to appreciate that different products might be needed atdifferent points in the menstrual cycle. This often leads women on anexpensive search for a better cosmetic or cleansing product, but thissearch is handicapped by the fact that each product may work best foronly one part of the cycle. What is needed, and what is claimed here, isa set of dermatological preparations whose formulations are specializedfor administration at different times during the hormonal cycle. Aplurality of such preparations would be packaged so that the customercan be reminded to use different formulations appropriate to differentparts of the hormonal cycle.

3. SUMMARY OF THE INVENTION

It is an object of this invention to improve skin cosmesis orconditioning by using different formulations of the dermatologicalpreparation in a sequence that suits the needs of the skin at differentpoints of the hormonal cycle. In its simplest implementation, this wouldbe a two-phase skin treatment, such as a cosmetic, lotion or soap whoseformulation changes to balance the differing states of hydration andreactivity of the skin during the early and late phases of the cycle.

It is also an object of this invention to facilitate improvements to theappearance or condition of the skin by ensuring that a plurality offormulations can be identified and delivered conveniently for use atdifferent times of a hormonal cycle.

It is a further object of this invention to teach a method by which sucha product could be packaged to permit the convenient purchase anddispensing of the different formulations in a manner that could beeasily sequenced with the hormonal cycle.

4. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the basic premise of the present invention.

FIG. 2 illustrates one embodiment of the present invention.

FIG. 3 illustrates another embodiment of the present invention.

5. DETAILED DESCRIPTION OF THE INVENTION

In general, the present disclosure describes hormonally-timeddermatological preparations. For easier understanding, specificembodiments of present invention are shown in the drawings. However, thepresent invention is not limited to the example embodiments describebelow.

Methods to time, produce and package a sequence of dermatologicalformulations is described in FIGS. 1, 2 and 3. FIG. 1 illustrates thebasic premise of the invention. It has three panels that illustrate, inpanel A, the pattern of cycling of estrogen 2 and progesterone 4 in anormal menstrual period of 28 days. Below, in B, is illustrated a commonregimen of hormone replacement therapy for a postmenopausal woman inwhich conjugated estrogens are administered from day 4 to day 18 aftermenstruation begins 6, and then progesterone is administered togetherwith the estrogen for the last 10 days of the cycle 8. Panel C of FIG. 1shows the simplest embodiment of the invention in which two formulationsare supplied, a first formulation 10 designed to match the needs of theskin during the estrogen phase and a second formulation 20 for useduring the phase when progesterone is also taken. The actual number andcomposition of formulations could vary depending upon the target user.In one embodiment of the method, the formulation supplied to a postmenopausal woman on hormone replacement therapy would vary in fatcontent from one part of the cycle to the next. During the early phase,when estrogen administration enhances hydration and thickening of theskin, and when the skin is faster to heal, the first formulation 10would be lighter and less oily. During the second part of the cycle,when progesterone exerts a braking effect on the estrogenic effects, thesecond formulation 20 would contain more fat or humectants to protectthe skin and to increase its state of hydration. A simple pair ofexemplary preparations is shown in Table I below, but many suchcombinations could be used to achieve the required effect.

TABLE 1 Formulation 1 Formulation 2 Almond oil 2.5 2.5 Cetyl Alcohol 0.80.8 Stearic acid 20 20 Triethanolamine 1.8 1.8 Water 69.5 68 Glycerol 55 Preservative 0.2 0.2 Perfume 0.2 0.2 Lanolin 1.5

In another embodiment designed for younger women or women withsensitivity to progesterone, the second formulation 20 administeredduring the late phase of the cycle, when acne is particularlyproblematic, would differ from the first formulation 10 by the additionof constituents to control sebum production, reduce bacterialproliferation and inflammation, or soothe or disguise rashing. Bysupplying two or more sequenced formulations, better control of skinproperties may be achieved with greater convenience to the user. Itwould be obvious to one normally skilled in the art that this inventioncould be adapted for situations in which the timing of hormones varied,or in which the formulations were altered for specific types of skin anddifferent skin conditions that are affected by hormonal cycling.

The invention includes means to deliver combinations of formulations.The preferred embodiment has the basic form of a package containing aplurality of reservoirs containing more than one dermatologicalformulation, and a method of labeling that identifies which formulationsare to be used at specific points in the menstrual cycle. FIGS. 2 and 3illustrate two exemplary packages that could be used to ensure thatsupplied formulations are used in accordance with cycled exogenoushormones or medications. FIG. 2 shows the simplest embodiment in which apair of fused tubes 30, 40 are differentiated by color or other labelingmeans. Each is filled with a different dermatological formulation. Inthis embodiment, appropriate for example, for women who receive hormonereplacement therapy in the form of two bottles of pills, the instructioncould be to use the contents of one tube during the time when onlyestrogen pills are taken, and use the product on the second tube whenboth estrogen and progesterone pills are taken together. In theembodiment illustrated in FIG. 3, the formulations are packagedindividually in a blister pack or other such means that have separatereservoirs 55 containing a quantity of material adequate for a singlesession or day. The embodiment in FIG. 3 shows the individualapplications in softgel capsules 50, 60 arranged circumferentially in apackage reminiscent of a familiar birth control dispenser, that providesproduct for a single month. Different types of product aredifferentiated by marking means such as color, location or otherlabeling 70. In this embodiment, the white capsules 55 are used for thefirst part of the cycle whereas the dark capsules 60 are used for thesecond part of the cycle. Additional labeling is needed 80 to identifythe product further and provide instructions for safe use. It would beobvious to one skilled in the art that other types of packaging could beemployed to practice this method. Further, this method could be adaptedeasily to dispense two or more formulations appropriate for use in womenwho experience endogenous hormonal cycling after puberty and prior tomenopause. Alternative forms of packaging to practice this inventionwould be obvious to one normally skilled in the art. The examplesprovided herein are intended only to illustrate the invention and not tolimit its scope.

1. A dermatological preparation, comprising at least one pharmaceuticalformulation to be administered according to the phase of a menstrualcycle.
 2. The dermatological preparation according to claim 1, whereinsaid at least one pharmaceutical formulation exhibits a watercomposition of at least 50%.
 3. The dermatological preparation accordingto claim 1, wherein said at least one pharmaceutical formulationexhibits a humectants composition of at least 20%.
 4. The dermatologicalpreparation according to claim 1, wherein said at least onepharmaceutical formulation exhibits a sebum content control agentcomposition of at least 0.5%.
 5. The dermatological preparationaccording to claim 1, wherein said at least one pharmaceuticalformulation contains constituents to control bacterial proliferation, tocontrol inflammation, to control rash, or combination thereof.
 6. Adermatological preparation comprising at least two pharmaceuticalformulations to be administered during different phases of a menstrualcycle, where said at least two pharmaceutical formulations differ intheir chemical composition in order to suit the different needs of theuser at different phases of the menstrual cycle.
 7. The dermatologicalpreparation according to claim 6, wherein the difference between said atleast two pharmaceutical formulations includes a difference in watercontent.
 8. The dermatological preparation according to claim 6, whereinthe difference between said at least two pharmaceutical formulationsincludes a difference in humectants content.
 9. The dermatologicalpreparation according to claim 6, wherein the difference between said atleast two pharmaceutical formulations includes a difference in dryingagents.
 10. The dermatological preparation according to claim 6, whereinsaid difference between the at least two pharmaceutical formulationsincludes a difference in antibiotic content.
 11. A dermatologicalpreparation consisting of at least two different pharmaceuticalformulation for administration during different phases of hormonereplacement therapy in post-menopausal women.
 12. The dermatologicalpreparation according to claims 1, 6 or 11, wherein said dermatologicalpreparation is in form of soap, cosmetic, or lotion.
 13. Thedermatological preparation according to claims 6 or 11, wherein saiddermatological preparation is delivered in a package that designates thephase during which each different pharmaceutical formulation should beused.